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The Efficacy of Bevacizumab Combined With m-FOLFOXIRI in Borderline Resectable Colorectal Liver Metastases

NCT03711240 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-13

No results posted yet for this study

Summary

This single-arm study will evaluate the resection rate of liver metastases in patients with metastatic colorectal cancer and borderline unresectable liver metastases receiving treatment with bevacizumab in combination with modified-FOLFOXIRI as first line treatment. Patients will receive bevacizumab (5 mg/kg) plus modified-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and fluorouracil 2400 mg/m2 as a 46-h continuous infusion) every 14 days as neoadjuvant chemotherapy regimen. This study treatment will continue until surgery, disease progression, unacceptable toxicity, or patient refusal.

Conditions

Interventions

DRUG

bevacizumab

5mg/kg iv day 1 every 2 weeks

DRUG

Oxaliplatin

85mg/m2 2-hour iv infusion, day 1 every 2 weeks

DRUG

Irinotecan

150mg/m2 1.5-hour iv infusion, day 1 every 2 weeks

DRUG

Leucovorin

200mg/m2 2-hour iv infusion, day 1 every 2 weeks

DRUG

5-FU

2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Shang Hung Chen · National Health Research Institutes, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2020-10-30
Completion
2020-10-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03711240 on ClinicalTrials.gov